Senior Manager, Stability Strategy

BioMarin Pharmaceutical•Novato, CA

6d•Remote

About The Position

The Senior Manager, Stability Strategy is a senior individual contributor and product-aligned stability subject matter expert. The role defines and owns stability strategies for assigned products from development through commercialization, independently designing, justifying, and defending approaches in complex or ambiguous situations. It supports multiple modalities and leads complex investigations and cross-functional initiatives. The position oversees stability program execution and data analysis, including study design, testing strategy, expiry and retest period assessment, shelf-life projections, trend detection, and risk mitigation. It supports product changes, comparability assessments, technology transfers, and lifecycle management, and authors or reviews technical documentation and regulatory submission materials. The role works with quality, analytical, supply, and other partner teams to align and execute stability strategies. The role does not require time onsite and involves significant virtual meetings and computer-based data analysis and document authoring or review, which can be performed from home. There are no regular travel requirements. The stated office shift is Monday through Friday, 8 a.m. to 5 p.m.

Requirements

10 or more years of experience in biotechnology, pharmaceuticals, or another highly regulated industry.
Demonstrated experience defining and managing stability programs across development and commercial phases of the product lifecycle.
Strong experience interpreting stability data to support expiry and/or retest decisions.
Strong working knowledge of ICH guidelines, global regulatory expectations, and statistical approaches for stability analysis.
Experience participating in health agency inspections.
BA/BS in Life Sciences or a related field.
Ability to work in a role involving significant virtual meetings and computer-based data analysis and document authoring or review.
Ability to contribute to workplace safety and environmental responsibility, including identifying hazards, reporting incidents, and participating in EHS initiatives and training.

Nice To Haves

12 or more years of biotechnology and/or pharmaceutical industry experience, including at least 2 years in a stability role.
Experience with multiple modalities, such as small molecules, biologics, or oligonucleotides.
Experience managing stability programs with atypical strategies through development and into commercialization.
Strong experience writing stability reports and summaries for INDs, BLAs, and other regulatory submissions.
Demonstrated ability to defend stability decisions to regulators.
Excellent interpersonal and communication skills, with the ability to influence diverse stakeholders and drive cross-functional decisions.
Proficiency with Veeva, LIMS, and JMP.
Advanced degree.

Responsibilities

Own stability strategy for assigned products across development and commercial stages.
Design and maintain stability programs, including study conditions, testing strategies, and bracketing and matrixing approaches.
Define and defend approaches for complex scenarios, including accelerated development, reduced testing designs, SKU coverage, and bridging strategies.
Align stability strategies with product knowledge, supply considerations, development phase, and regulatory expectations.
Lead stability support for process changes, comparability assessments, technology transfers, and lifecycle management, including post-approval changes.
Make risk-based decisions when regulatory or industry precedent is unclear.
Author and review stability reports, summaries, technical documents, protocols, SOPs, test methods, and risk or impact assessments.
Lead investigations into significant deviations and quality events, including events at external testing laboratories.
Drive continuous improvement while maintaining compliance and supporting operational and commercial needs.
Initiate and own QMS records related to the stability program, including deviations, change controls, and CAPAs.
Analyze stability data to justify expiry and retest periods, assess degradation pathways and product risk, and support storage and shipping recommendations, including allowable excursions.
Identify emerging trends and risks and drive mitigation strategies.
Support the generation, maintenance, and reporting of stability data for clinical and commercial programs covering drug substance, drug product, and critical intermediates.
Oversee stability data collection and analysis, using sources such as LIMS or CofAs and data trending software such as JMP.
Perform statistical analysis for shelf-life projections, end-of-shelf-life specification proposals, stability-batch monitoring, and detection of potentially adverse trends.
Partner with Product Quality Leaders on statistical calculations for product comparability acceptance criteria.
Author and review stability sections for global regulatory submissions, including IND/CTA, NDA/BLA, MAA, and post-approval changes.
Prepare annual report stability sections and summaries for regulatory submissions, including US, Canadian, and Brazilian reports.
Support responses to health authority questions and information requests.
Ensure strategies align with ICH guidelines and applicable global regulatory requirements.
Coordinate with departments such as External Quality, QC, Analytical, and PQL teams to integrate stability testing into product development and execution.
Translate complex stability considerations into actionable recommendations and drive cross-functional alignment through scientific credibility and influence.
Coordinate placement of annual commitment batches into stability programs in accordance with regulatory commitments.
Contribute to environmental protection, injury prevention, and continual improvement of EHS management systems; identify hazards, report incidents, and participate in EHS initiatives and training.